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Liver ResectionNCT06905041

Preoperative Anemia Affected to Postoperative Outcomes in Liver Resection

An observational study of Liver Resection and Anemia, run by Chiang Mai University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To assess the impact of preoperative anemia on postoperative outcomes in patients undergoing liver resection Read more about this study

Who is it for?
Ages 20 to 75 years
How many people
728 participants
Where
No sites listed yet
Study dates
31 Mar 2025to 31 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • Adult, Older adult

Study population: Patients who underwent elective liver resection in setting hospital during January, 2006 to December, 2024

Who may be able to join

  • All genders, age 20 to 75 years old who undergoing elective liver resection
  • American Society of Anesthesiologists (ASA) physical status classification of I-III

Who cannot join

  • Living donor liver resection
  • Withdrawal criteria:
  • Unresectable tumor
  • Cardiac arrest during operation

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Warangkana Lapisatepun, MD. PhD. contact

+66910688716

warangkana.c@cmu.ac.th

Worakitti Lapisatepun, MD. contact

0910688761

worakitti.l@cmu.ac.th

About this study

Official title: The Impact of Preoperative Anemia on Postoperative Outcomes in Liver Resection: A Propensity Score Matching Analysis

To assess the impact of preoperative anemia on postoperative outcomes in patients undergoing liver resection

Read the detailed description

Globally, anemia affects approximately 33% of the population, with nearly 50% of cases attributed to iron deficiency. In Thailand, anemia remains a significant public health issue, with prevalence rates of 24% among women of reproductive age, 23.8% among nonpregnant women, and 32.2% among pregnant women. Iron deficiency anemia (IDA) is the leading and most common cause of anemia worldwide, and it is highly prevalent in Thailand. Moreover, the situation in Thailand is often exacerbated by the widespread incidence of thalassemia and hemoglobinopathies, with 30% to 40% of the population carrying thalassemia genes.

According to the World Health Organization (WHO), anemia is defined as a hemoglobin concentration of less than 12 g/dL in nonpregnant women and less than 13 g/dL in men. The prevalence of preoperative anemia among surgical patients has been reported to be between 32% and 48%. Preoperative anemia is one of the most common medical conditions encountered in surgical patients, with a prevalence ranging from 20% to 45% depending on the type of surgery. Specifically, in hepato-pancreato-biliary (HPB) surgery, 16.9% to 32.8% of patients present with anemia prior to surgery.

Preoperative anemia is a well-established predictor of the need for perioperative blood transfusions in liver resection, as supported by multiple studies. Perioperative allogeneic blood transfusions are associated with numerous adverse outcomes, both short-term and long-term. These include transfusion reactions, increased rates of postoperative infections, cardiopulmonary and thromboembolic events, prolonged mechanical ventilation, re-operations, extended hospital and ICU stays, elevated postoperative morbidity, increased tumor recurrence, reduced disease-specific survival, and decreased overall survival.

A large retrospective study reported a prevalence of preoperative anemia at 32.8%, which was associated with higher rates of postoperative major morbidities and mortality. After adjusting for confounding factors-such as age, type of liver resection, ASA classification, preoperative laboratory results, comorbidities, functional status, and diagnosis-patients with preoperative anemia were found to have a 21% higher risk of developing major morbidities within 30 days (adjusted odds ratio 1.21, 1.09-1.33). These morbidities included organ space infections, sepsis, septic shock, prolonged postoperative ventilator use (>48 hours), unplanned reintubation, pneumonia, and acute kidney injury requiring dialysis. However, preoperative anemia was not associated with increased postoperative mortality in liver resection (adjusted odds ratio 0.88, 0.66-1.16).

Furthermore, a retrospective study involving 4,170 patients demonstrated that preoperative anemia was associated with an increased risk of major postoperative complications compared to patients without anemia (24% versus 19%). After adjusting for confounders, including age, sex, race, obesity, extent of liver resection, comorbidities, functional status, and clinical and biochemical markers of liver dysfunction and portal hypertension, preoperative anemia was linked to a threefold increased risk of blood transfusion, a twofold increased risk of prolonged hospitalization, and higher healthcare costs in anemic patients. These findings suggest that anemia significantly impacts resource utilization in liver resection.

In a broader context, a study involving 227,425 patients from the ACS-NSQIP database who underwent major non-cardiac surgery reported that 30.4% of patients had preoperative anemia. The results showed that preoperative anemia was associated with increased morbidity and mortality within 30 days, even after adjusting for several known risk factors, including transfusions. Despite this evidence, there are limited studies specifically evaluating the impact of preoperative anemia on outcomes in specific surgeries, particularly liver resection.

The findings of this study could enhance physicians' understanding of the impact of preoperative anemia on postoperative outcomes, emphasizing the importance of its evaluation and treatment. Therefore, the assessment and management of preoperative anemia are essential components of patient blood management in liver resection. Proper assessment and timely intervention could mitigate associated risks and improve surgical outcomes.

Keywords
Preoperative anemia, liver resection, posteoperative complication
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06905041
Study groupRoleWhat they receive
Anemia groupThe patients who had preoperative anemia (hemoglobin levels < 12 g/dL in female and < 13 g/dL in male) before liver resection
No anemia groupThe patients who did not have preoperative anemia before liver resection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative 30-day morbidity rate

    • To determine whether preoperative anemia is associated with increased risk of postoperative 30-day morbidity in patients undergoing liver resection.

    Measured: From enrollment to the postoperative day 30

Secondary outcomes (1)
  1. Allogenic blood transfusion, comprehensive complication index, postoperative outcomes, and mortality rate

    • To determine the incidence of preoperative anemia in liver resection patients.
    • To determine the incidence of postoperative 30-day morbidities rate
    • To evaluated the postoperative 30-day morbidities rate, classified using:
    • Clavien Dindo classification
    • Comprehensive complication index (CCI)
    • To determine postoperative major complication, defined as Clavien-Dindo classification grade III or higher or CCI > 40
    • To assess the length of hospital stay
    • To assess the length of ICU stay and ventilator day
    • To evaluate postoperative 30-day mortality

    Measured: From enrollment to the postoperative day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start31 Mar 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
728 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06905041
Sponsor's protocol ID
ANE-2568-0141
Status last verified
Mar 2025
First submitted
25 Mar 2025
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Resection and Anemia, run by Chiang Mai University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Warangkana Lapisatepun, MD. PhD. (+66910688716, warangkana.c@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative 30-day morbidity rate (time frame: From enrollment to the postoperative day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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